Multiple Myeloma (MM)Phase 1/2CASSANDRANCT05908409
A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies
A Phase 1/2 study testing IDP-121 in people with Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by IDP Discovery Pharma S.L. at 11 sites in Spain.
Trial summary
The main aims of this 2-part study are: Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Double Hit Lymphoma
- What is being tested?
- IDP-121
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 11 sitesSpain
- Study dates
- 5 Jun 2023to 22 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Performance status (ECOG) ≤ 2
- Life expectancy ≥3 months
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
- Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments.
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- Adequate hematological or biochemical parameters as specified below
- Hemoglobin > 8.0 g/dl (without transfusion support within 7 days)
- Platelets count > 75 x109/L (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109/L.
- Absolute neutrophil count (ANC) > 0.75 x109/L (without G-CSF support within 7 days)
- Aspartate transaminase (AST): <2.5 x the upper limit range (in patients with no liver metastases or <5 x ULN in patients with liver metastases)
- Alanine transaminase (ALT): < 2.5 x the upper limit range (in patients with no liver metastases or <5 x ULN in patients with liver metastases)
- Total bilirubin: < 2 x the upper limit range.
- Calculated or measured creatinine clearance: >30 mL/min (calculated from the Cockcroft-Gault formula).
- Left ventricular ejection fraction > 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.
Who cannot join
- Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed.
- Pregnant or lactating women; men and women of reproductive potential* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinenence).
- A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)
- History of clinically significant hypotension.
- History of clinically significant allergic or hyper-sensitivity reactions.
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- History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to):
- Thromboembolism
- Peripheral arterial disease
- Vasculitis
- Other relevant diseases or adverse clinical conditions:
- Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
- Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months).
- History of significant neurological or psychiatric disorders
- Clinically significant or active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
- The patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels <50 copies/mL; Hepatitis B surface antigen-positive or active hepatitis C infection, unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels; or active CMV infection (IgM positive).
- Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.
- Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment
- Limitation of the patient's ability to comply with the treatment or follow-up protocol.
- If a COVID-19 vaccine is administered, it should be done >72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase").
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Spain11 sites, 11 recruiting
- Recruiting
Hospital Universitari Vall d'hebron
Barcelona, 08035
+34934893806, fbosch@vhio.net
Francesc Bosch Albareda
- Recruiting
Hospital Durán i Reynals - ICO L´Hospitalet
Barcelona
Anna María Sureda Balari
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
+34917792877, jmartinezlo1967@gmail.com
jmarti01@med.ucm.es
- Recruiting
Hospital Universitario La Paz
Madrid
Pilar Gómez
- Recruiting
Hospital Universitario Puerta de Hierro
Madrid
Belén Navarro
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
valentin.cabanas@gmail.com
Valentín Cabañas Perianes
- Recruiting
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
+34923291316, mvmateos@usal.es
María Victoria Mateos Manteca
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
+34942202573, ocioem@unican.es
Enrique Ocio San Miguel
- Recruiting
Hospital Universitario Virgen del Rocio
Seville
Estrella Carrillo
- Recruiting
Hospital de Clinico Universitario de Valencia
Valencia
Blanca Ferrer Lores
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Araceli Rubio
About this study
Official title: A Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies (CASSANDRA)
The main aims of this 2-part study are:
- Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL).
- Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).
Read the detailed description
This study is an open-label, multicenter, Phase 1/2 study with a Dose-Escalation phase (Phase 1) and an Expansion phase (Phase 2).
Dose-Escalation (Phase 1): The dose-escalation phase will follow a classical 3+3 design but the first patient (sentinel) will be treated at dose level 1 (0.015 mg/kg) for one cycle, and, if no Dose-Limiting Toxicities (DLTs) occur, at dose level 2 (0.032 mg/kg) from cycle 2 onwards. Once the patient 1 (sentinel) is allowed to enter dose level 2, two additional patients will be enrolled to complete the cohort at dose level 2, and the dose-escalation phase will continue the 3+3 design. DLTs will be assessed based on the safety observed in cycle 1 (28 days) for all patients except for patient 1 (sentinel) where DLT will be assessed on safety observed in cycle 1 (at dose level 1) and cycle 2 (at dose level 2). For the first trial patient (sentinel) a single cycle will be completed (28 days) at dose level 0.015 mg/kg. Doses will not be escalated before all patients entered at the current dose level have been treated and observed for at least one complete cycle (28 days) at the intended dose- cohort IDP-121 dose and the number of DLTs among those patients in their first cycle has been determined. Before each escalation, Clinical Investigators will be consulted as part of a cohort review meeting to review and discuss all data (including safety, PK, PD and efficacy data) and agree on a dose-escalation, as appropriate.
During the study, the Sponsor and Investigators may request that cohorts be enlarged or that intermediate doses between 2 planned escalation steps be explored based on all data existing at that time, including emerging safety and efficacy data and determinations of PK and PD. Also, the study will allow for alternative IDP-121 doses and/or schedules to be evaluated based on emerging data e.g., once a week dosing of IDP-121 (instead of twice a week). Data from all patients at all dose levels will be used to guide further dose-escalation or/and the MTD/RP2D.
Expansion-Phase (Phase 2): Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy. Patients will receive 28-day cycles up to a maximum of 12 cycles of treatment or until any IDP-121 treatment discontinuation criteria are met (disease progression, unacceptable toxicity, etc). Patients in the Expansion- Phase may include one or more tumor types from those evaluated in dose-escalation.
- Conditions
- Multiple Myeloma (MM), Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Double Hit Lymphoma, High Grade B-Cell Lymphoma, Not Otherwise Specified, Chronic Lymphocytic Leukemia (CLL), Triple Hit Lymphoma
- Being tested
- IDP-121
- Medical subject headings
- Multiple Myeloma, Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDP-121Drug
IDP-121 is a new chemical entity specifically designed to directly target cMyc protein that has demonstrated activity in multiple liquid and solid tumor cell lines and preclinical animal models
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kg | Experimental | IDP-121 will be administered as a 4-hours i.v. infusion twice a week (3 weeks on, 1 week off) on days 1, 4, 8, 11, 15 and 18 in 28-day treatment (a Cycle) (Table 4). A minimum interval of 3 days and no more than 5 days between dosing is allowed.
Patients can receive IDP-121 until disease progression, unacceptable toxicity or any other discontinuation criteria are met, or for a maximum treatment period of 1 year, whichever occurs first. Patients at the RP2D may enter the expansion phase. Receives: Drug: IDP-121 |
| Expansion Phase: IDP-121 at RP2D | Experimental | Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy. DP-121 will be administered as a 4-hours i.v. infusion twice a week (3 weeks on, 1 week off) on days 1, 4, 8, 11, 15 and 18 in 28-day treatment Patients can receive IDP-121 until disease progression, unacceptable toxicity or any other discontinuation criteria are met, or for a maximum treatment period of 1 year, whichever occurs first. Receives: Drug: IDP-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Dose Escalation
Maximum tolerated dose (MTD)
Measured: Through 1 treatment cycle (each cycle is 28 days)
Phase 1: Dose Escalation
Recommended phase 2 dose (RP2D)
Measured: Through 12 treatment cycles (each cylce is 28 days) or until End of Treatment, whatever occurs first
Phase 2: Expansion Phase
Overall Response Rate (ORR)
Measured: Based on iwCLL 20181, IMWG 20162, and the Lugano 20143 criteria for CLL, MM and Lymphomas, respectively; assessed at the end of study (12 months)
Secondary outcomes (5)
Phase 2: Expansion Phase
Duration of response (DoR)
Measured: From disease response to disease progression, up to 12 months
Phase 2: Expansion Phase
Time to progression (TTP)
Measured: From the first treatment day to day of the objective disease progression through study completion, an average of 12 months
Phase 2: Expansion Phase
Progression-free survival (PFS)
Measured: From first treatment day to the first sign of disease progression or death from any cause assessed up to 12 months.
Phase 2: Expansion Phase
Event-free survival (EFS)
Measured: From first treatment day to disease progression, death, or discontinuation of treatment from any cause through study completion, an average of 12 months
Phase 2: Expansion Phase
Overall survival (OS)
Measured: From first treatment day to death from any cause, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start5 Jun 2023
- Primary completion22 Dec 2025 (estimated)
- Study completion22 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IDP Discovery Pharma S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Ocio San Miguel, MD, PhD, Principal investigator, Hospital Universitario Marqués de Valdecilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908409
- Sponsor's protocol ID
- IDP-121-1
- Acronym
- CASSANDRA
- Status last verified
- Apr 2025
- First submitted
- 3 May 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies (CASSANDRA)
- ClinicalTrials.gov ID
- NCT05908409
- Acronym / sponsor ID
- CASSANDRA / IDP-121-1
- Conditions
- Multiple Myeloma (MM), Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Double Hit Lymphoma, High Grade B-Cell Lymphoma, Not Otherwise Specified, Chronic Lymphocytic Leukemia (CLL), Triple Hit Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- IDP Discovery Pharma S.L.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 22 Dec 2025 (estimated)
- Study completion
- 22 Mar 2026 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aims of this 2-part study are:
- Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL).
- Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).
Detailed description
This study is an open-label, multicenter, Phase 1/2 study with a Dose-Escalation phase (Phase 1) and an Expansion phase (Phase 2).
Dose-Escalation (Phase 1): The dose-escalation phase will follow a classical 3+3 design but the first patient (sentinel) will be treated at dose level 1 (0.015 mg/kg) for one cycle, and, if no Dose-Limiting Toxicities (DLTs) occur, at dose level 2 (0.032 mg/kg) from cycle 2 onwards. Once the patient 1 (sentinel) is allowed to enter dose level 2, two additional patients will be enrolled to complete the cohort at dose level 2, and the dose-escalation phase will continue the 3+3 design. DLTs will be assessed based on the safety observed in cycle 1 (28 days) for all patients except for patient 1 (sentinel) where DLT will be assessed on safety observed in cycle 1 (at dose level 1) and cycle 2 (at dose level 2). For the first trial patient (sentinel) a single cycle will be completed (28 days) at dose level 0.015 mg/kg. Doses will not be escalated before all patients entered at the current dose level have been treated and observed for at least one complete cycle (28 days) at the intended dose- cohort IDP-121 dose and the number of DLTs among those patients in their first cycle has been determined. Before each escalation, Clinical Investigators will be consulted as part of a cohort review meeting to review and discuss all data (including safety, PK, PD and efficacy data) and agree on a dose-escalation, as appropriate.
During the study, the Sponsor and Investigators may request that cohorts be enlarged or that intermediate doses between 2 planned escalation steps be explored based on all data existing at that time, including emerging safety and efficacy data and determinations of PK and PD. Also, the study will allow for alternative IDP-121 doses and/or schedules to be evaluated based on emerging data e.g., once a week dosing of IDP-121 (instead of twice a week). Data from all patients at all dose levels will be used to guide further dose-escalation or/and the MTD/RP2D.
Expansion-Phase (Phase 2): Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy. Patients will receive 28-day cycles up to a maximum of 12 cycles of treatment or until any IDP-121 treatment discontinuation criteria are met (disease progression, unacceptable toxicity, etc). Patients in the Expansion- Phase may include one or more tumor types from those evaluated in dose-escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kg | Experimental | Drug: IDP-121IDP-121 will be administered as a 4-hours i.v. infusion twice a week (3 weeks on, 1 week off) on days 1, 4, 8, 11, 15 and 18 in 28-day treatment (a Cycle) (Table 4). A minimum interval of 3 days and no more than 5 days between dosing is allowed. Patients can receive IDP-121 until disease progression, unacceptable toxicity or any other discontinuation criteria are met, or for a maximum treatment period of 1 year, whichever occurs first. Patients at the RP2D may enter the expansion phase. |
| Expansion Phase: IDP-121 at RP2D | Experimental | Drug: IDP-121Additional 17 patients will be enrolled for treatment at the RP2D level to further study safety and evaluate efficacy. DP-121 will be administered as a 4-hours i.v. infusion twice a week (3 weeks on, 1 week off) on days 1, 4, 8, 11, 15 and 18 in 28-day treatment Patients can receive IDP-121 until disease progression, unacceptable toxicity or any other discontinuation criteria are met, or for a maximum treatment period of 1 year, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥18 years
- Performance status (ECOG) ≤ 2
- Life expectancy ≥3 months
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Key exclusion criteria (21 listed)
- Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade <2 symptomatic peripheral neuropathy is allowed.
- Pregnant or lactating women; men and women of reproductive potential* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinenence).
- A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
- History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)
- History of clinically significant hypotension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDP-121IDP-121 is a new chemical entity specifically designed to directly target cMyc protein that has demonstrated activity in multiple liquid and solid tumor cell lines and preclinical animal models | Drug | Dose Escalation: IDP-121 0.015 Up to 0.70 mg/kg, Expansion Phase: IDP-121 at RP2D |
Primary outcome
Phase 1: Dose Escalation
Time frame: Through 1 treatment cycle (each cycle is 28 days)
Maximum tolerated dose (MTD)
Phase 1: Dose Escalation
Time frame: Through 12 treatment cycles (each cylce is 28 days) or until End of Treatment, whatever occurs first
Recommended phase 2 dose (RP2D)
Phase 2: Expansion Phase
Time frame: Based on iwCLL 20181, IMWG 20162, and the Lugano 20143 criteria for CLL, MM and Lymphomas, respectively; assessed at the end of study (12 months)
Overall Response Rate (ORR)
5 secondary outcomes
Phase 2: Expansion Phase
Time frame: From disease response to disease progression, up to 12 months
Phase 2: Expansion Phase
Time frame: From the first treatment day to day of the objective disease progression through study completion, an average of 12 months
Phase 2: Expansion Phase
Time frame: From first treatment day to the first sign of disease progression or death from any cause assessed up to 12 months.
Phase 2: Expansion Phase
Time frame: From first treatment day to disease progression, death, or discontinuation of treatment from any cause through study completion, an average of 12 months
Phase 2: Expansion Phase
Time frame: From first treatment day to death from any cause, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Sponsor´s web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrique Ocio San Miguel, MD, PhD principal investigator
Hospital Universitario Marqués de Valdecilla
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IDP-121 in people with Multiple Myeloma (MM) and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by IDP Discovery Pharma S.L. at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Molina, PhD (+34669616086, d.molina@idp-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Dose Escalation (time frame: Through 1 treatment cycle (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.